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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00050518 |
The study seeks to define, with precision, the safety and efficacy of APSV, two dose potencies of one lot in vaccinia-naive adults. The ability of this vaccine to induce a classic �take� as defined by formation of a lesion at the injection site consistent with the �Jennerian� process (see Appendix A) and vaccine specific immune responses will be assessed. The local cutaneous lesion is considered to be a surrogate for clinical effectiveness of live, replicating smallpox vaccines. Neutralizing antibody formation has been correlated with takes for the Dryvax vaccine and is considered to be cross-protective for other orthopoxviruses, including variola. The study also seeks to characterize preliminarily the cell mediated immune (CMI) response to APSV (as compared to Dryvax).
Condition | Intervention | Phase |
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Smallpox |
Biological: Aventis Pasteur Smallpox Vaccine |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Dose Comparison, Parallel Assignment |
Official Title: | A Multicenter, Double-Blind, Randomized Study of the Safety and Efficacy of Aventis Pasteur's Smallpox Vaccine, USP (APSV) in Vaccinia-Naive Adults. |
Estimated Enrollment: | 444 |
A Multicenter, double blind, randomized trial in which each volunteer will receive one of 2 dose concentrations of one of two lots of Aventis Pasteur Smallpox Vaccine as a single vaccination (undiluted, 1:5 dilution). Volunteers without a take at day 7 - 9 will be offered a vaccination with Dryvax at the end of the study.
Ages Eligible for Study: | 18 Years to 32 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
INCLUSION CRITERIA:
(Note: Renal function is measured to ensure that subjects could meet criteria for use of cidofovir if needed).
EXCLUSION CRITERIA:
United States, Iowa | |
University of Iowa - Iowa City IA | |
Iowa City, Iowa, United States, 52242 | |
United States, Ohio | |
University of Cincinnati | |
Cincinnati, Ohio, United States, 45267-05 | |
Cincinnati Children's Hospital Med Ctr | |
Cincinnati, Ohio, United States, 45229 | |
United States, Tennessee | |
Vanderbilt University | |
Nashville, Tennessee, United States, 37232-26 |
Study ID Numbers: | 02-054 |
Study First Received: | December 11, 2002 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00050518 |
Health Authority: | United States: Food and Drug Administration |
Smallpox Aventis Pasteur Vaccine |
Virus Diseases Smallpox Poxviridae Infections Vaccinia DNA Virus Infections |